PK-VIS

In-line Automatic Visual Inspection Tester

In-line and Off-line Non-Invasive, Non-Destructive Automatic Visual Inspection (AVI) System of containers with pharmaceutical product at high production speed

Highlights

  • High inspection solutions flexibility
  • High stability of application system and validation principles
  • Hardware and Software optimization according to customer URS
  • AVI no limited visual defects detection
  • CFR part 11 compliance and 4.0 full integration

Tech Specification and Features

Technical Features

  • Container Application: Ampoules, BFS, Carpoules, PFS, Vials
  • Products: Powder, Lyo, Liquid
  • Container Dimensions: Diam. 14 - 54 mm
  • Fill level: [1 - 100] ml
  • Speed: Up to 600 Cpm
  • Technology: AVI (Automatic Visual Inspection)
  • Inspection Features: Non-Invasive, Non-Destructive
  • Inspection Capabilities: Visual inspection: - Presence of Foreign Particulate Matters, - Cosmetic Defects,- False Fill Level and Product Color.

Additional Plus

  • Computer-based automated measurement system: image acquisition, processing, and decision making.
  • High resolution cameras coupled with illuminators automatically positioned so to magnify regions of interest and designed according to defect type.
  • Maximum accessibility of electrical and mechanical component for easy maintenance.
  • Connections to Active Directory and VPN router for machine remote access.
  • Validation package guarantees complete and efficient regulatory compliance.
  • Full batch control testing: fast, reliable and repeatable.
  • Testing of all nominal production line speed.
  • MES (Manufacturing Execution System connection) allows remote machine data exchange & download
  • Real time display of statistical raw data
  • Easy, quick and safe remote access
  • Easy cleaning

Technology

  • It is an automated camera based measurement technology detecting visual defects, such as:
    • Presence of Foreign Particulate Matters
    • Cosmetic Defects
    • False Fill Level and Product Color
  • For each inspected container, a collection of images is acquired using high resolution video cameras under designed illumination conditions. Defects on the package are identified and/or measured by dedicated image processing algorithms and the package is classified as conforming or non-conforming with given standards.

Quality Assurance

  • Equipment test method refers to:
    • United States Pharmacopeia:
      • USP General Chapter <1>: “Injections”
      • USP Gen. Chap. <790>: “Visible Particulates In Injections”
      • USP Gen. Chap. <1790>: “Visual Inspection of Injections”
    • European Pharmacopeia § 2.9.20:
      • “Particulate Contamination: Visible Particles”
      • Machines Qualification and Validation requirements stated in EU Annex 15
  • All computerized systems are designed according to ISPE GAMP 5 guidelines and to comply with FDA 21 CFR Part 11 and EU Annex 11